Cleared Traditional

K070291 - MEDIX NATAL CARE INTENSIVE CARE INCUBATOR

K070291 is the FDA 510(k) clearance for MEDIX NATAL CARE INTENSIVE CARE INCUBATOR by Medix I.C.S.A.. It is a Class 2 General Hospital device (product code FMZ) cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K070291 · Medix I.C.S.A. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
234d
Days
Class 2
Risk

K070291 is an FDA 510(k) clearance for the MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Medix I.C.S.A. (Houston, US). The FDA issued a Cleared decision on September 21, 2007 after a review of 234 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5400 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Medix I.C.S.A. devices

Submission Details

510(k) Number K070291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2007
Decision Date September 21, 2007
Days to Decision 234 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 129d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMZ Incubator, Neonatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMZ Incubator, Neonatal

All 30
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K070291.
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